Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Recruiting now · Phase 3

Conditions studied: Colonic Neoplasms, Neoplasms, Colon

In brief

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

Key facts

Study ID

NCT05855200

Run by

GlaxoSmithKline

People needed

892

Starts

2023-08-01

Expected to finish

2031-03-27

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has untreated pathologically confirmed colon adenocarcinoma
• Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
• Has radiologically evaluable disease
• Has a tumor demonstrating the presence of either dMMR status or MSI-H

You may not qualify if…

• Has distant metastatic disease.
• Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer
• Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
• Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
• Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
• Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
• Has a history of allogenic stem cell transplantation or organ transplantation
• Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
• Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
• Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX

Where it is running

• GSK Investigational Site — Akron, Ohio, United States (enrolling)
• GSK Investigational Site — Sioux Falls, South Dakota, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — Durham, North Carolina, United States (enrolling)
• GSK Investigational Site — New Haven, Connecticut, United States (enrolling)
• GSK Investigational Site — Sioux Falls, South Dakota, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — The Bronx, New York, United States (enrolling)
• GSK Investigational Site — Naperville, Illinois, United States (enrolling)
• GSK Investigational Site — Westwood, Kansas, United States (enrolling)
• GSK Investigational Site — Cincinnati, Ohio, United States (enrolling)
• GSK Investigational Site — Sioux Falls, South Dakota, United States (enrolling)
• GSK Investigational Site — Chicago, Illinois, United States (enrolling)
• GSK Investigational Site — Bethesda, Maryland, United States (enrolling)
• GSK Investigational Site — Chicago, Illinois, United States (enrolling)
• GSK Investigational Site — Detroit, Michigan, United States (enrolling)
• GSK Investigational Site — Minneapolis, Minnesota, United States (enrolling)
• GSK Investigational Site — Tucson, Arizona, United States (enrolling)
• GSK Investigational Site — Naperville, Illinois, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — Grand Island, Nebraska, United States (enrolling)
• GSK Investigational Site — Omaha, Nebraska, United States (enrolling)
• GSK Investigational Site — Sioux Falls, South Dakota, United States (enrolling)

Full record on ClinicalTrials.gov

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